UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031816 |
|---|---|
| Receipt number | R000036339 |
| Scientific Title | Transtrochanteric rotational osteotomy and re-sphere of collapse for osteonecrosis of the femoral head, based on artificial bone filling |
| Date of disclosure of the study information | 2018/03/20 |
| Last modified on | 2018/06/07 13:51:56 |
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Basic information
Public title
Transtrochanteric rotational osteotomy and re-sphere of collapse for osteonecrosis of the femoral head, based on artificial bone filling
Acronym
Transtrochanteric rotational osteotomy and re-sphere of collapse for osteonecrosis of the femoral head
Scientific Title
Transtrochanteric rotational osteotomy and re-sphere of collapse for osteonecrosis of the femoral head, based on artificial bone filling
Scientific Title:Acronym
Transtrochanteric rotational osteotomy and re-sphere of collapse for osteonecrosis of the femoral head
Region
| Japan |
Condition
Condition
osteonecrosis of the femoral head
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is evaluate a clinical outcome after transtrochanteric rotational osteotomy and re-sphere of collapse for the femoral head in patients with osteonecrosis based on artificial bone filling
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Osteoarthritis after procedure using radiography
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Under transtrochanteric rotational osteotomy , artificial bone filling is performed for collapse of the femoral head in patients with osteonecrosis
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 55 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients who will undergo transtrochanteric rotational osteotomy with collapse of osteonecrosis of the femoral head
Key exclusion criteria
The patients that an effect is not obtained by transtrochanteric rotational osteotomy and artificial bone filling
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takuaki Yamamoto |
Organization
Fukuoka University Faculty of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka
TEL
092-801-1011
yamamotot@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuro Ishimatsu |
Organization
Fukuoka University Faculty of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka
TEL
092-801-1011
Homepage URL
md140002@yahoo.co.jp
Sponsor or person
Institute
Fukuoka University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2018 | Year | 03 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 20 | Day |
Last modified on
| 2018 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036339
